The following data is part of a premarket notification filed by Vsm Medtech Ltd. with the FDA for Automated Non-invasive Blood Pressure Monitor, Model Bpm-100.
| Device ID | K994423 |
| 510k Number | K994423 |
| Device Name: | AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | VSM MEDTECH LTD. 555 13TH ST. NW Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein VSM MEDTECH LTD. 555 13TH ST. NW Washington, DC 20004 -1109 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-29 |
| Decision Date | 2000-03-28 |